The list of new standards, current draft standards and projects is a selection that might be relevant for our clients. It therefore does not claim to be complete. The compilation has been made very carefully and serves as an overview for you. However, errors cannot be excluded, and we cannot assume any liability. The selection draws information from the following standards committees:
DIN EN ISO 10993-15 (Standard)
Biological evaluation of medical devices
Part 15: Identification and quantification of degradation products from metals and alloys
Date: 2023-07
IEC 60601-2-57 (Standard)
Medical Electrical Equipment
Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use
Date: 2023-07
ISO/TS 4549 (Standard)
Orthotics
Method for testing the reliability of microprocessor-controlled ankle moment units of ankle-foot orthoses
Date: 2023-07
ISO/TS 11796 (Norm)(English Only)
Biological evaluation of medical devices
Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
Date: 2023-07
ISO 21535 (Standard)
Non-active surgical implants – Joint replacement implants
Specific requirements for hip-joint replacement implants
Date: 2023-07
ISO 21536 (Standard)
Non-active surgical implants — Joint replacement implants
Specific requirements for knee-joint replacement implants
Date: 2023-07
ISO 22926 (Standard)
Implants for surgery
Specification and verification of synthetic anatomical bone models for testing
Date: 2023-07
DIN EN ISO 80601-2-80 (Draft)
Medical Electrical Equipment
Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
Date: 2023-07
ISO/AWI 21762 (Projekte) (English Only)
Humane Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt werden
Anwendung des Risikomanagements
Date: 2023-07-24
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